Golden rules for Sponsor: <em>Project Management of Clinical Trials</em>


Golden rules contain GCP requirements, best practice and practical examples within:

  • Skills of a successful clinical project/trial manager
  • Communication
  • Documentation
  • Outsourcing and vendors
  • Authorisation of clinical trial
  • Investigational Medicinal Products (IMP)
  • Investigators and trial sites
  • Data management
  • Pharmacovigilance for clinical trials


Golden rules provide a clear overview of activities before, during and after the trial.

Albert Einstein:
Success = Work + Play
Successful business = Knowledge + Quality
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